Breast cancer
Conditions
Interventions
A:Usage and dosage of recombinant anti-HER2 humanized monoclonal antibody for injection: freeze-dried powder for injection
Intravenous infusion of 0.2mg/kg after reolysis and dilution, and single medication.
B:Usage and dosage of recombinant anti-HER2 humanized monoclonal antibody for injection: freeze-dried powder for injection
Intravenous infusion after reolysis and dilution, 1mg/kg, single dose.
C:Usage and dosage of recombinant anti-HER2 humanized monoclonal antibody for injection: freeze-dried powder for injection
Intravenous infusion, 2mg/kg, and single dose.
D:Usage and dosage of recombinant anti-HER2 humanized monoclonal antibody for injection: freeze-dried powder for injection
E:Chinese generic name: Trastuzumab for injection (Herceptin, Herceptin) usage: freeze-dried powder for injection (including diluent)
F:Usage and dosage of recombinant anti-HER2 humanized monoclonal antibody for injection: freeze-dried powder for injection
Intravenous infusion after reolysis and dilution, 6mg/kg, single dose.
Sponsors
Drug Clinical Trial Center of Xiangya Third Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male, 18-45 years old; 2. The body mass index (BMI) of subjects with body weight = 50kg was between 19 and 25 kg / m2 (including the boundary value); 3. According to the results of physical examination, medical history, vital signs, ECG and clinical laboratory examination, the researchers believe that the subjects are in good health, without history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities; comprehensive physical examination shows that there are no abnormalities or clinical symptoms in body temperature, blood pressure, heart rate, respiratory status and various laboratory examinations Clinical significance (according to the judgment of clinicians); 4. Subjects with left ventricular ejection fraction (LVEF) > 60%; 5. Subjects who must give informed consent to the study before the trial and sign the written informed consent voluntarily; 6. The subjects can communicate well with the researchers and complete the research according to the research regulations.
Exclusion criteria
Exclusion criteria: 1. Subjects who had undergone surgery within 4 weeks before the trial; 2. Subjects with allergic constitution or known allergy to this product or any of its excipients; 3. Patients with a history of any clinical serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other diseases or physiological conditions that can interfere with the test results; 4. Patients undergoing treatment for gastrointestinal problems, spasm, peptic ulcer, urinary tract infarction, mechanical intestinal obstruction, ureteral spasm, biliary tract disease, depression or liver disease; 5. Patients with gastrointestinal, liver and kidney diseases that can affect drug absorption or metabolism; 6. Patients with known severe bleeding factors that can affect venous blood collection; 7. Patients with history of malignant tumor; 8. Patients who had used any drugs to inhibit or induce liver metabolism 30 days before or during the trial (e.g. inducers barbiturates, carbamazepines, phenytoin, glucocorticoids, Omeprazole; inhibitors SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives, hypnotics, verapamil, fluoroquinolones, antidepressants) Histamines); 9. Patients with abnormal ECG (with clinical significance) or abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 BPM); 10. HIV, HBsAg, HCV or Treponema pallidum antibody positive patients; 11. Alcoholics or subjects who frequently drank alcohol within 6 months before the experiment, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of 40% alcohol or 150 ml of wine); 12. Smokers or subjects who smoked more than 5 cigarettes per day for 3 months before the experiment; 13. Subjects of drug abuse or subjects who used soft drugs (such as cannabis) three months before the trial or hard drugs (such as cocaine, phencyclidine, etc.) one year before the trial; 14. Any subjects who are allergic to food or have special dietary requirements can not follow the same diet; 15. Subjects who drink too much tea, coffee and / or caffeinated drinks every day (more than 8 cups, 1 cup = 250ml); 16. Subjects who had taken any drugs within 14 days before the trial; 17. Subjects who took any clinical trial drug or participated in any drug clinical trial within 3 months before the trial; 18. Subjects who donated blood or were sampled as subjects 3 months before the experiment; 19. Subjects who may not be able to complete the study for other reasons or who are considered not to be included by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Drug Clinical Trial Center of Xiangya Third Hospital of Central South University
Outcome results
None listed